True Copy
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
A true copy is a copy of an original record — paper or electronic, in the same or a different format — that has been verified to preserve the full content and meaning of the original, including all data and relevant metadata. Once verified, a true copy can be used in place of the original and, in some cases, the original can then be retired.
For static records, a true copy may be a photocopy or scan verified against the original. For dynamic records, a true copy must preserve the dynamic functionality and associated metadata — a flat PDF of an interactive data file is generally not a true copy because it loses reprocessing capability and audit history.
The verification step is essential: an unverified copy is just a copy. Organizations should define who is authorized to certify true copies and how the verification (content and metadata completeness) is documented.
- —Preserves full content and meaning, including relevant metadata.
- —Must be verified against the original before use.
- —Dynamic records require the dynamic functionality be preserved.
- —A verified true copy may replace the original for retention.
MHRA GXP Data Integrity Guidance (2018), true copy definition; WHO TRS 1033 Annex 4 (2021).
Frequently asked questions
What is True Copy?
A true copy is a copy of an original record — paper or electronic, in the same or a different format — that has been verified to preserve the full content and meaning of the original, including all data and relevant metadata. Once verified, a true copy can be used in place of the original and, in some cases, the original can then be retired.
Which regulations cover True Copy?
MHRA GXP Data Integrity Guidance (2018), true copy definition; WHO TRS 1033 Annex 4 (2021).